BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMWEB PLUS

    MDR report key: 20866676 · Received December 6, 2024

    Report

    Report Number
    1217183-2024-00010
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 6, 2024
    Report Date
    January 13, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT FROM ON (B)(6) 2024, PATIENT BLOOD GAS SAMPLES FOR A BABY STARTED TO RETRIEVE DEMOGRAPHICS FOR THE MOTHER. TWO SAMPLES WERE ANALYZED ON NOV 6. PATIENT MRN FOR THE BABY WAS QUERIED TO LIS. THE DOWNLOADED DEMOGRAPHIC MATCHED THE PATIENT DEMOGRAPHIC IN THE LOCAL GEM DATABASE. THE OPERATOR AMENDED THE PATIENT RECORD FOR THE SAMPLE ANALYZED ON OCT 22 AT 23:49:32. THE DEMOGRAPHIC OF THE BABY WAS MODIFIED TO THE MOTHER'S NAME (ACCORDING TO THE INFORMATION PROVIDED), WHICH WAS DOWNLOADED FROM LIS. UPON INVESTIGATION OF THE LOGS PROVIDED, IT WAS OBSERVED THAT SEVERAL SEQUENTIAL DEMOGRAPHIC QUERIES WERE MADE. IN ALL THOSE CASES, THE RECEIVED INFORMATION FROM LIS MATCHED THE ID QUERIED. NO ANOMALY WAS OBSERVED ON THE GEMWEB PLUS. REVIEW OF THE DATA IDENTIFIED THAT THE ISSUE WITH THE DEMOGRAPHICS IS AN ISSUE WITHIN SYNAPSE. NO EVIDENCE OF A GEM SOFTWARE ISSUE WAS OBSERVED.

    Additional Manufacturer Narrative · 0

    THIS IS AN INITIAL REPORT. INVESTIGATION IS CURRENTLY ONGOING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE NNU NURSE REPORTED THAT THE PATIENT BLOOD GAS SAMPLES FOR THE BABY STARTED TO RETRIEVE DEMOGRAPHICS FOR THE MOTHER. GEMWEB PLUS WAS CHECKED AND ALL RESULTS FOR THE BABY HAD BEEN CHANGED TO THE MOTHER'S DEMOGRAPHICS. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2470967 GEMWEB PLUS MEDICAL DEVICE DATA SYSTEM OUG INSTRUMENTATION LABORATORY CO. 6.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown